Clinical Intelligence

FDA approves Kyprolis therapy for multiple myeloma

Friday, January 22, 2016

Amgen has announced that the FDA has approved the supplemental New Drug Application (sNDA) of Kyprolis (carfilzomib) for Injection in combination with dexamethasone or with lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy. The FDA also approved Kyprolis as a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy. This FDA decision converts to full approval the initial accelerated approval Kyprolis received in July 2012 as a single agent.

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FDA grants Priority Review for Genentech’s Venetoclax NDA

Wednesday, January 13, 2016

The FDA has accepted the New Drug Application (NDA) and granted Priority Review for Roche Group member Genentech’s venetoclax for the treatment of people with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy, including those with 17p deletion. Venetoclax is a small molecule inhibitor of the BCL-2 protein being developed in partnership with AbbVie, and was granted Breakthrough Therapy designation by the FDA in April 2015 for the treatment of people with previously treated (relapsed or refractory) CLL with 17p deletion.

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Regenxbio’s RGX-111 gets FDA Rare Pediatric Disease designation

Monday, January 4, 2016

Regenxbio, a Rockville, Md.-based biotechnology company focused on the development, commercialization and licensing of recombinant adeno-associated virus (AAV) gene therapy, today announced that the FDA has granted Rare Pediatric Disease designation to RGX-111, the company’s investigational gene therapy product candidate for the treatment of mucopolysaccharidosis type I (MPS I).

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